BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLEMENT C3

    MDR report key: 8671652 · Received June 5, 2019

    Report

    Report Number
    1628664-2019-00371
    Event Type
    Malfunction
    Date Received
    June 5, 2019
    Date of Event
    November 19, 2018
    Report Date
    June 5, 2019
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CZW
    UDI-DI
    00380740019730
    PMA / PMN Number
    K983441
    Removal / Correction Number
    1628664-05/21/19-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FIELD ACTION IS ASSOCIATED WITH ALL LOTS OF THE FOLLOWING ASSAYS: ARCHITECT COMPLEMENT C3 (LN 09D96-21) UDI (B)(4), ARCHITECT IMMUNOGLOBULIN A (LN 09D98-21) UDI (B)(4), ARCHITECT IMMUNOGLOBULIN G (09D99-21) UDI (B)(4), ARCHITECT IMMUNOGLOBULIN M (LN 01E01-21) UDI (B)(4), ARCHITECT APOLIPOPROTEIN A1 (09D92-21) UDI (B)(4), ARCHITECT COMPLEMENT C4 (09D97-21) UDI (B)(4), ARCHITECT HAPTOGLOBIN (09D91-21) UDI (B)(4), ARCHITECT APOLIPOPROTEIN B (09D93-21) UDI (B)(4), AND ARCHITECT TRANSFERRIN (01E04-21 UDI (B)(4), 01E04-41 UDI (B)(4)). A PRODUCT CORRECTION LETTER WAS ISSUED ON 16MAY2019 TO CUSTOMERS WHO HAVE RECEIVED SHIPMENTS OF ANY OF THE IMPACTED PRODUCTS. THE LETTER INSTRUCTS THE CUSTOMER TO IMMEDIATELY DISCONTINUE THE USE OF THE EDTA PLASMA SAMPLES WHEN USING ANY OF THE IMPACTED PRODUCTS. THE INVESTIGATION INTO THIS MATTER FOUND THAT THE EDTA SPECIMEN TYPE IS NO LONGER ACCEPTABLE FOR USE WITH ARCHITECT COMPLEMENT C3, ARCHITECT IMMUNOGLOBULIN A, ARCHITECT IMMUNOGLOBULIN G, ARCHITECT IMMUNOGLOBULIN M, ARCHITECT APOLIPOPROTEIN A1, ARCHITECT COMPLEMENT C4, AND ARCHITECT HAPTOGLOBIN. ADDITIONALLY, THE SPECIMEN STORAGE INFORMATION IS BEING REVISED FOR THE ARCHITECT COMPLEMENT C3, ARCHITECT IMMUNOGLOBULIN A, ARCHITECT IMMUNOGLOBULIN G, AND ARCHITECT IMMUNOGLOBULIN M ASSAYS. ALL REAGENT KITS WILL INCLUDE A KIT STUFFER WITH THIS INFORMATION UNTIL THE INSTRUCTIONS FOR USE (IFU) FOR THESE ARCHITECT PRODUCTS IS UPDATED.

    Description of Event or Problem · 1

    ABBOTT IDENTIFIED THAT AN UPDATE TO THE REAGENT AND SPECIMEN COLLECTION AND HANDLING/PREPARATION FOR ANALYSIS SECTIONS OF THE INSTRUCTIONS FOR USE (IFU) FOR THE INCLUDED ARCHITECT PRODUCTS WAS REQUIRED FOR THE FOLLOWING ISSUES: BASED ON RECENT FIBRINOGEN INTERFERENCE TESTING, IT HAS BEEN DETERMINED THAT EDTA PLASMA SAMPLES ARE NO LONGER ACCEPTABLE FOR USE WITH THE FOLLOWING ASSAYS: APOLIPOPROTEIN A1 (APO A1), COMPLEMENT C3 (C3), COMPLEMENT C4 (C4), HAPTOGLOBIN, IMMUNOGLOBULIN G (IGG), IMMUNOGLOBULIN A (IGA), AND IMMUNOGLOBULIN M (IGM). THERE IS A POTENTIAL FOR FALSELY DEPRESSED RESULTS DUE TO FIBRINOGEN INTERFERENCE WITH EDTA SPECIMENS FOR THESE PRODUCTS. ADDITIONALLY, FOR THE COMPLEMENT C4 ASSAY, THERE IS A POTENTIAL FOR FALSELY DEPRESSED RESULTS DUE TO FIBRINOGEN INTERFERENCE WITH HEPARIN TUBES AT THE CONCENTRATIONS > 1512 MG/DL IN LITHIUM HEPARIN TUBES AND >859 MG/DL IN SODIUM HEPARIN TUBES. ADDITIONALLY, BASED ON RECENT TESTING, THE SPECIMEN STORAGE INFORMATION IS BEING REVISED FOR THE FOLLOWING ASSAYS: IGG, IGA, IGM, AND C3. THE MAXIMUM STORAGE TIME FOR SAMPLES STORED AT 2-8 DEGREES C AND 20-25 DEGREES C WERE INACCURATELY STATED. THESE ISSUES WERE IDENTIFIED THROUGH INTERNAL TESTING AND NO CUSTOMER REPORTS HAVE BEEN RECEIVED TO DATE. THERE HAVE BEEN NO REPORTED INJURIES AS A RESULT OF THESE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464631 COMPLEMENT C3 C3 CZW ABBOTT MANUFACTURING INC 00380740019730

    Patients

    Seq Age Sex Outcome Treatment
    1